Status:
COMPLETED
WelChol® and Insulin in Treating Patients With Type 2 Diabetes
Lead Sponsor:
Daiichi Sankyo
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to see how safe and effective and tolerable the use of WelChol® is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic drugs
Eligibility Criteria
Inclusion
- Ages 18 - 75 years, inclusive
- Diagnosed with type 2 diabetes
- Stable insulin therapy for 6 weeks
- Stable dose of any other antidiabetic medications for 90 days
- Hemoglobin A1c value between 7.5% to 9.5%
- C peptide greater than 0.5 ng/mL
- Prescribed ADA diet
Exclusion
- History of type 1 diabetes or ketoacidosis
- History of pancreatitis
- Uncontrolled hypertension
- Allergy or toxic response to colesevelam or any of its components
- Serum LDL-C less than 60 mg/dL
- Serum TG greater than 500 mg/dL
- Body mass index (BMI) greater than 45 kg/m2-
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00151749
Start Date
June 1 2004
End Date
December 1 2005
Last Update
January 18 2012
Active Locations (47)
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1
Tuscumbia, Alabama, United States
2
Sierra Vista, Arizona, United States
3
Jonesboro, Arkansas, United States
4
Searcy, Arkansas, United States